Common Cold
Conditions
Keywords
Acute infectious rhinitis, Rhinosinusitis, Respiratory tract infection, Nasal irrigation
Brief summary
Healsea® Rescue\* is a CE-marked class I medical device. This is a saline-based nasal spray supplemented with a natural Symbiofilm™ extract (0.04%) isolated from the marine bacteria. Healsea® Rescue\* is indicated in adults for the treatment of symptoms of acute respiratory tract infections, rhinitis or rhinosinusitis, and for reduction of the swelling of the nasal mucosa. The goal of this clinical trial is to demonstrate that hypertonic saline solution and Symbiofilm™ act in a synergistic manner to alleviate symptoms of the acute rhinitis phase resulting in better efficacy than isotonic saline solution without Symbiofilm™ used as Placebo in adults with early symptoms of common cold / acute infectious rhinitis.
Detailed description
Upper respiratory tract infections (URTIs) and sino-nasal symptoms are very frequent, especially during the fall and the winter. The common cold is caused by a variety of viruses such as human rhinoviruses and influenza viruses. The incidence of acute rhinitis/rhinosinusitis is very high, estimated to occur from 2 to 5 times per year in the average adult. However, the natural course of acute rhinitis in adults is favorable since 75% of persons have a reduction or resolution of symptoms within 7 days. Only 0.5 to 2.0% of subjects develop secondary bacterial sinusitis requiring antibiotic prescription. Bacterial over infections and progression to a chronic state are favoured by the formation of biofilms, which facilitate bacterial growth and persistence as well as reducing antibiotic efficacy. The socioeconomic impact of acute rhinitis is well established: visits to GP, additional prescriptions and over prescription of antibiotics, workdays lost. Although clinical evidence from well-designed trials is scarce, European and American guidelines for acute rhinosinusitis recommend daily nasal saline irrigation for reduction of the severity of symptoms and for speeding recovery. The exact mechanisms by which nasal irrigation works are not known. However, most of the experts agree that it is primarily a mechanical intervention leading to direct cleansing of the nasal mucosa. Hypertonic saline solutions are generally considered as more effective than isotonic saline solutions in reducing nasal symptoms in the acute phase. Nevertheless, the efficacy of such solution remains moderate. Healsea® Rescue\* is a CE-marked class I medical device. This is a saline-based nasal spray supplemented with a natural Symbiofilm™ extract (0.04%) isolated from the marine bacteria Bacillus licheniformis T14. The nasal solution is hypertonic (NaCl 2.7%). Symbiofilm™ is an exopolysaccharide with emulsifying properties and in vitro antibiofilm activity and detachment properties against various bacterial pathogens. Symbiofilm™ also protects in vitro human nasal epithelial cells viability after Rhinovirus, Adenovirus, Coronavirus OC43 and Flu infection. The aim of this study is to demonstrate that hypertonic saline solution and Symbiofilm™ act in a synergistic manner to alleviate symptoms of the acute rhinitis phase resulting in better efficacy than isotonic saline solution without Symbiofilm™ used as Placebo. The study comprises two parts: \- Part 1 (Day1-Day 8): treatment of the acute phase • with Healsea® Rescue\*, 2 puffs in each nostril 2 times per day during 7 days (14 intakes of the investigational device). or • with isotonic nasal spray (Placebo), 2 puffs in each nostril 2 times per day during 7 days (14 intakes of the Placebo). \- Part 2 (Day 9-Day 13/15): follow-up phase. The study comprises two visits and one telephone call: * Visit 1 (V1) at Day 1 * Telephone call at Day 8 * End of study visit (Visit 2, V2) between Day 13 and Day 15.
Interventions
DEVICEHealsea Rescue*
Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
DEVICEPlacebo
Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
Sponsors
Lallemand Pharma AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male/Female subjects \>18 years 2. Acute infectious rhinitis/rhinosinusitis for ≤48h before trial entry 3. Symptoms of headache, muscle ache, chilliness, sore throat, blocked nose, runny nose, cough, sneezing with a score ≤9 (according to a self-rated symptom score; scale: 0 → 3 \[0: no symptom to 3: severe intensity\]) 4. At least one of these symptoms: sore throat, runny nose or blocked nose (i.e., with a score ≥1) 5. Willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the information consent form 6. Patient with a smartphone and an internet connection.
Exclusion criteria
1. Known hypersensitivity/allergy to any component of the test device 2. Medical history or any current disease that is considered by the investigator as a reason for non-inclusion 3. Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps 4. History of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores 5. Antibiotic intake within 2 weeks before screening 6. Systemic or local corticosteroids (nasal route or inhalation) within 4 weeks before screening 7. Antihistamines intake for allergy when treatment was started from less than 4 weeks 8. Chronic decongestant use 9. Recent (within the previous 2 days) intake of a common cold medicine that in the opinion of the investigator may influence symptom score at screening (NSAID, nasal decongestants, cough medicines) 10. Pregnant/Lactating female or absence of efficient contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC (Area Under Curve) of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) During First 8 Days of Symptoms as Compared Between Both Groups - Full Analysis Set (FAS) | Treatment period, from Day 1 to Day 8 | The WURSS-21 questionnaire scores the severity and functional impact of a cold (items 2 to 11 and 12 to 20 respectively) plus 2 items for global severity and global change (items 1 and 21 respectively). Each item is scored from 0 (not sick / Do not have this symptom / Not at all / Very much better) to 7 (severely, severe, severely, very much worse) for global assessment, symptoms, functional impairment and global change respectively. The question 21 is not included in the calculation of the total score of the WURSS-21. The minimum WURSS-21 score is zero (0) and the maximum WURSS-21 score is one hundred forty (140). The questionnaire was completed in a diary once daily in the evening, taking into account the symptoms from the morning to the evening, during Day 2-Day 8 (day of the end of treatment). At Day 1, the WURSS-21 was completed during the visit. After Day 8, it was assessed once daily until the subject feels not sick for two consecutive days. |
| AUC (Area Under Curve) of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) During First 8 Days of Symptoms as Compared Between Both Groups - Per Protocol Set (PP) | Treatment period, from Day 1 to Day 8 | The WURSS-21 questionnaire scores the severity and functional impact of a cold (items 2 to 11 and 12 to 20 respectively) plus 2 items for global severity and global change (items 1 and 21 respectively). Each item is scored from 0 (not sick / Do not have this symptom / Not at all / Very much better) to 7 (severely, severe, severely, very much worse) for global assessment, symptoms, functional impairment and global change respectively. The question 21 is not included in the calulation of the total score of the WURSS-21. The minimum WURSS-21 score is zero (0) and the maximum WURSS-21 score is one hundred forty (140). The questionnaire was completed in a diary once daily in the evening, taking into account the symptoms from the morning to the evening, during Day 2-Day 8 (day of the end of treatment). At Day 1, the WURSS-21 was completed during the visit. After Day 8, it was assessed once daily until the subject feels not sick for two consecutive days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Runny Nose | Through study completion, up to Day 15 | For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days. |
| Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Plugged Nose | Through study completion, up to Day 15 | For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days. |
| Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sneezing | Through study completion, up to Day 15 | For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days. |
| Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sore Throat | Through study completion, up to Day 15 | For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days. |
| Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Cough | Through study completion, up to Day 15 | For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days. |
| Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Scratchy Throat | Through study completion, up to Day 15 | For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days. |
| Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Hoarseness | Through study completion, up to Day 15 | For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days. |
| AUC of the Symptoms Sub-score (Items 2-11) of the WURSS-21 During First 8 Days | Treatment period, from Day 1 to Day 8 | The Symptoms' WURSS-21 questionnaire scores the severity of the cold (items 2 to 11). Each item is scored from 0 (Do not have this symptom) to 7 (Severe). The minimum Symptoms' WURSS-21 score is zero (0) and the maximum is seventy (70). The questionnaire was completed in a diary once daily in the evening, taking into account the symptoms from the morning to the evening, during Day 2-Day 8 (day of the end of treatment). At Day 1, the Symptoms' WURSS-21 was completed during the visit. After Day 8, it was assessed once daily until the subject feels not sick for two consecutive days. |
| Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Chest Congestion | Through study completion, up to Day 15 | For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days. |
| Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Feeling Tired | Through study completion, up to Day 15 | For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days. |
| Cumulative Number of Days of Usual Medication for Common Cold Use | Through study completion, up to Day 15 | Concomitant treatments (antipyretics, systemic or local mucolytics, decongestants, antitussives, antibiotics) use will be reported in the e-diary by the patient throughout the study, validated by the investigator at the end of study visit before being reported in the e-CRF. |
| Subject Satisfaction Regarding Ease of Use of the Nasal Spray | Between Day 13 and Day 15 | At end of study visit (V2) subject satisfaction regarding ease of use will be recorded using a 4-points categorical scale (How would you characterize the use of Healsea® Rescue\* nasal spray? 0: not easy ; 1: pretty easy ; 2: easy ; 3: very easy). |
| Characterization of Residual Taste by the Subject | Between Day 13 and Day 15 | At end of study visit (V2) the residual taste after using the spray will be assessed by the subject using a 4-points categorical scale (How would you characterize the residual taste after spraying Healsea® Rescue\*?0: not pleasant ; 1: neutral ; 2: pleasant ; 3: very pleasant). |
| Characterization of Cleansing and Moistening of Nasal Mucosa With the Prescribed Treatment by the Subject | Between Day 13 and Day 15 | At end of study visit (V2) cleansing and moistening of nasal mucosa will be assessed by the subject using a 4-points categorical scale (How would you characterize the cleansing and moistening of nasal mucosa with Healsea® Rescue\*?0: no improvement ; 1: slight improvement ; 2: moderate improvement; 3: very clear improvement). |
| Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Head Congestion | Through study completion, up to Day 15 | For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days. |
| AUC of the Quality of Life Sub-score (Items 12-20) of the WURSS-21 During First 8 Days | Treatment period, from Day 1 to Day 8 | The Quality-of-Life' WURSS-21 questionnaire scores the impact of the cold on quality of life (items 12 to 20). Each item is scored from 0 (Not at all) to 7 (Severely). The minimum Quality-of-Life' WURSS-21 score is zero (0) and the maximum is sixty three (63). The questionnaire was completed in a diary once daily in the evening, taking into account the symptoms from the morning to the evening, during Day 2-Day 8 (day of the end of treatment). At Day 1, the Symptoms' WURSS-21 was completed during the visit. After Day 8, it was assessed once daily until the subject feels not sick for two consecutive days |
Countries
Bulgaria
Participant flow
Recruitment details
First patient first visit: 14th December 2022 Last patient last visit: 31 th January 2023 Location: Bulgaria, 1 site
Participants by arm
| Arm | Count |
|---|---|
| Healsea Rescue* Group Subjects will receive Healsea Rescue\* according to its intended use.
Healsea Rescue\*: Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days. | 100 |
| Placebo Group Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Placebo: Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days. | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Healsea Rescue* Group | Total | Placebo Group |
|---|---|---|---|
| Age, Continuous | 36.1 Years STANDARD_DEVIATION 14 | 35.3 Years STANDARD_DEVIATION 13.7 | 34.4 Years STANDARD_DEVIATION 13.4 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Bulgaria | 100 participants | 200 participants | 100 participants |
| Sex: Female, Male Female | 57 Participants | 111 Participants | 54 Participants |
| Sex: Female, Male Male | 43 Participants | 89 Participants | 46 Participants |
| Total WURSS-21 score at baseline | 37.7 units on a scale STANDARD_DEVIATION 20.1 | 37.4 units on a scale STANDARD_DEVIATION 19.1 | 37.0 units on a scale STANDARD_DEVIATION 18.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 10 / 100 | 9 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
AUC (Area Under Curve) of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) During First 8 Days of Symptoms as Compared Between Both Groups - Full Analysis Set (FAS)
The WURSS-21 questionnaire scores the severity and functional impact of a cold (items 2 to 11 and 12 to 20 respectively) plus 2 items for global severity and global change (items 1 and 21 respectively). Each item is scored from 0 (not sick / Do not have this symptom / Not at all / Very much better) to 7 (severely, severe, severely, very much worse) for global assessment, symptoms, functional impairment and global change respectively. The question 21 is not included in the calculation of the total score of the WURSS-21. The minimum WURSS-21 score is zero (0) and the maximum WURSS-21 score is one hundred forty (140). The questionnaire was completed in a diary once daily in the evening, taking into account the symptoms from the morning to the evening, during Day 2-Day 8 (day of the end of treatment). At Day 1, the WURSS-21 was completed during the visit. After Day 8, it was assessed once daily until the subject feels not sick for two consecutive days.
Time frame: Treatment period, from Day 1 to Day 8
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healsea Rescue* Group | AUC (Area Under Curve) of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) During First 8 Days of Symptoms as Compared Between Both Groups - Full Analysis Set (FAS) | 135.60 Score on a scale*day | Standard Deviation 89.88 |
| Placebo Group | AUC (Area Under Curve) of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) During First 8 Days of Symptoms as Compared Between Both Groups - Full Analysis Set (FAS) | 177.77 Score on a scale*day | Standard Deviation 125.4 |
Comparison: Comparison of the mean AUC of WURSS-21 scores assessed during the first 8 days of the study between both groups - FAS setp-value: 0.0192Wilcoxon (Mann-Whitney)
Primary
AUC (Area Under Curve) of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) During First 8 Days of Symptoms as Compared Between Both Groups - Per Protocol Set (PP)
The WURSS-21 questionnaire scores the severity and functional impact of a cold (items 2 to 11 and 12 to 20 respectively) plus 2 items for global severity and global change (items 1 and 21 respectively). Each item is scored from 0 (not sick / Do not have this symptom / Not at all / Very much better) to 7 (severely, severe, severely, very much worse) for global assessment, symptoms, functional impairment and global change respectively. The question 21 is not included in the calulation of the total score of the WURSS-21. The minimum WURSS-21 score is zero (0) and the maximum WURSS-21 score is one hundred forty (140). The questionnaire was completed in a diary once daily in the evening, taking into account the symptoms from the morning to the evening, during Day 2-Day 8 (day of the end of treatment). At Day 1, the WURSS-21 was completed during the visit. After Day 8, it was assessed once daily until the subject feels not sick for two consecutive days.
Time frame: Treatment period, from Day 1 to Day 8
Population: Per Protocol Set (PP)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healsea Rescue* Group | AUC (Area Under Curve) of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) During First 8 Days of Symptoms as Compared Between Both Groups - Per Protocol Set (PP) | 122.50 score on a scale*day | Standard Deviation 83.42 |
| Placebo Group | AUC (Area Under Curve) of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) During First 8 Days of Symptoms as Compared Between Both Groups - Per Protocol Set (PP) | 163.21 score on a scale*day | Standard Deviation 114 |
Comparison: Comparison of the mean AUC of WURSS-21 scores assessed during the first 8 days of the study between both groups - PP setp-value: 0.0296Wilcoxon (Mann-Whitney)
Secondary
AUC of the Quality of Life Sub-score (Items 12-20) of the WURSS-21 During First 8 Days
The Quality-of-Life' WURSS-21 questionnaire scores the impact of the cold on quality of life (items 12 to 20). Each item is scored from 0 (Not at all) to 7 (Severely). The minimum Quality-of-Life' WURSS-21 score is zero (0) and the maximum is sixty three (63). The questionnaire was completed in a diary once daily in the evening, taking into account the symptoms from the morning to the evening, during Day 2-Day 8 (day of the end of treatment). At Day 1, the Symptoms' WURSS-21 was completed during the visit. After Day 8, it was assessed once daily until the subject feels not sick for two consecutive days
Time frame: Treatment period, from Day 1 to Day 8
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healsea Rescue* Group | AUC of the Quality of Life Sub-score (Items 12-20) of the WURSS-21 During First 8 Days | 54.36 score on a sub-scale*day | Standard Deviation 59.49 |
| Placebo Group | AUC of the Quality of Life Sub-score (Items 12-20) of the WURSS-21 During First 8 Days | 74.50 score on a sub-scale*day | Standard Deviation 79.15 |
p-value: 0.0081Wilcoxon (Mann-Whitney)
Secondary
AUC of the Symptoms Sub-score (Items 2-11) of the WURSS-21 During First 8 Days
The Symptoms' WURSS-21 questionnaire scores the severity of the cold (items 2 to 11). Each item is scored from 0 (Do not have this symptom) to 7 (Severe). The minimum Symptoms' WURSS-21 score is zero (0) and the maximum is seventy (70). The questionnaire was completed in a diary once daily in the evening, taking into account the symptoms from the morning to the evening, during Day 2-Day 8 (day of the end of treatment). At Day 1, the Symptoms' WURSS-21 was completed during the visit. After Day 8, it was assessed once daily until the subject feels not sick for two consecutive days.
Time frame: Treatment period, from Day 1 to Day 8
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healsea Rescue* Group | AUC of the Symptoms Sub-score (Items 2-11) of the WURSS-21 During First 8 Days | 67.11 score on a sub-scale*day | Standard Deviation 43.09 |
| Placebo Group | AUC of the Symptoms Sub-score (Items 2-11) of the WURSS-21 During First 8 Days | 87.57 score on a sub-scale*day | Standard Deviation 53.15 |
p-value: 0.0085Wilcoxon (Mann-Whitney)
Secondary
Characterization of Cleansing and Moistening of Nasal Mucosa With the Prescribed Treatment by the Subject
At end of study visit (V2) cleansing and moistening of nasal mucosa will be assessed by the subject using a 4-points categorical scale (How would you characterize the cleansing and moistening of nasal mucosa with Healsea® Rescue\*?0: no improvement ; 1: slight improvement ; 2: moderate improvement; 3: very clear improvement).
Time frame: Between Day 13 and Day 15
Population: Full Analysis Set
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Healsea Rescue* Group | Characterization of Cleansing and Moistening of Nasal Mucosa With the Prescribed Treatment by the Subject | no improvement | 3 Participants |
| Healsea Rescue* Group | Characterization of Cleansing and Moistening of Nasal Mucosa With the Prescribed Treatment by the Subject | slight improvement | 11 Participants |
| Healsea Rescue* Group | Characterization of Cleansing and Moistening of Nasal Mucosa With the Prescribed Treatment by the Subject | moderate improvement | 47 Participants |
| Healsea Rescue* Group | Characterization of Cleansing and Moistening of Nasal Mucosa With the Prescribed Treatment by the Subject | very clear improvement | 39 Participants |
| Placebo Group | Characterization of Cleansing and Moistening of Nasal Mucosa With the Prescribed Treatment by the Subject | very clear improvement | 47 Participants |
| Placebo Group | Characterization of Cleansing and Moistening of Nasal Mucosa With the Prescribed Treatment by the Subject | no improvement | 5 Participants |
| Placebo Group | Characterization of Cleansing and Moistening of Nasal Mucosa With the Prescribed Treatment by the Subject | moderate improvement | 37 Participants |
| Placebo Group | Characterization of Cleansing and Moistening of Nasal Mucosa With the Prescribed Treatment by the Subject | slight improvement | 11 Participants |
Comparison: 0.05 global significance level (type I error rate)p-value: 0.483Fisher Exact
Secondary
Characterization of Residual Taste by the Subject
At end of study visit (V2) the residual taste after using the spray will be assessed by the subject using a 4-points categorical scale (How would you characterize the residual taste after spraying Healsea® Rescue\*?0: not pleasant ; 1: neutral ; 2: pleasant ; 3: very pleasant).
Time frame: Between Day 13 and Day 15
Population: Full Analysis Set
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Healsea Rescue* Group | Characterization of Residual Taste by the Subject | residual taste not pleasant | 4 Participants |
| Healsea Rescue* Group | Characterization of Residual Taste by the Subject | residual taste neutral | 59 Participants |
| Healsea Rescue* Group | Characterization of Residual Taste by the Subject | residual taste pleasant | 21 Participants |
| Healsea Rescue* Group | Characterization of Residual Taste by the Subject | residual taste very pleasant | 16 Participants |
| Placebo Group | Characterization of Residual Taste by the Subject | residual taste very pleasant | 15 Participants |
| Placebo Group | Characterization of Residual Taste by the Subject | residual taste not pleasant | 3 Participants |
| Placebo Group | Characterization of Residual Taste by the Subject | residual taste pleasant | 21 Participants |
| Placebo Group | Characterization of Residual Taste by the Subject | residual taste neutral | 61 Participants |
Comparison: 0.05 global significance level (type I error rate)p-value: 0.988Fisher Exact
Secondary
Cumulative Number of Days of Usual Medication for Common Cold Use
Concomitant treatments (antipyretics, systemic or local mucolytics, decongestants, antitussives, antibiotics) use will be reported in the e-diary by the patient throughout the study, validated by the investigator at the end of study visit before being reported in the e-CRF.
Time frame: Through study completion, up to Day 15
Population: Full Analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healsea Rescue* Group | Cumulative Number of Days of Usual Medication for Common Cold Use | 7 days |
| Placebo Group | Cumulative Number of Days of Usual Medication for Common Cold Use | 15 days |
Comparison: 0.05 global significance level (type I error rate)p-value: 0.605Fisher Exact
Secondary
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Chest Congestion
For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days.
Time frame: Through study completion, up to Day 15
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healsea Rescue* Group | Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Chest Congestion | 3.1 days | Standard Deviation 3.8 |
| Placebo Group | Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Chest Congestion | 3.2 days | Standard Deviation 4 |
Comparison: 0.05 global significance level (type I error rate)p-value: 0.582Wilcoxon (Mann-Whitney)
Secondary
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Cough
For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days.
Time frame: Through study completion, up to Day 15
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healsea Rescue* Group | Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Cough | 4.2 days | Standard Deviation 4.3 |
| Placebo Group | Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Cough | 4.3 days | Standard Deviation 3.9 |
Comparison: 0.05 global significance level (type I error rate)p-value: 0.339Wilcoxon (Mann-Whitney)
Secondary
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Feeling Tired
For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days.
Time frame: Through study completion, up to Day 15
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healsea Rescue* Group | Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Feeling Tired | 4.7 days | Standard Deviation 3.9 |
| Placebo Group | Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Feeling Tired | 4.4 days | Standard Deviation 3.8 |
Comparison: 0.05 global significance level (type I error rate)p-value: 0.743Wilcoxon (Mann-Whitney)
Secondary
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Head Congestion
For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days.
Time frame: Through study completion, up to Day 15
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healsea Rescue* Group | Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Head Congestion | 4.7 days | Standard Deviation 4.2 |
| Placebo Group | Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Head Congestion | 3.9 days | Standard Deviation 3.8 |
Comparison: 0.05 global significance level (type I error rate)p-value: 0.906Wilcoxon (Mann-Whitney)
Secondary
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Hoarseness
For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days.
Time frame: Through study completion, up to Day 15
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healsea Rescue* Group | Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Hoarseness | 3.7 days | Standard Deviation 3.9 |
| Placebo Group | Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Hoarseness | 3.9 days | Standard Deviation 3.9 |
Comparison: 0.05 global significance level (type I error rate)p-value: 0.298Wilcoxon (Mann-Whitney)
Secondary
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Plugged Nose
For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days.
Time frame: Through study completion, up to Day 15
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healsea Rescue* Group | Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Plugged Nose | 5.9 days | Standard Deviation 3.1 |
| Placebo Group | Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Plugged Nose | 6.9 days | Standard Deviation 3.2 |
p-value: 0.0107Wilcoxon (Mann-Whitney)
Secondary
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Runny Nose
For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days.
Time frame: Through study completion, up to Day 15
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healsea Rescue* Group | Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Runny Nose | 6.1 days | Standard Deviation 3.1 |
| Placebo Group | Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Runny Nose | 7.2 days | Standard Deviation 3.1 |
p-value: 0.005Wilcoxon (Mann-Whitney)
Secondary
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Scratchy Throat
For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days.
Time frame: Through study completion, up to Day 15
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healsea Rescue* Group | Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Scratchy Throat | 4.5 days | Standard Deviation 3.9 |
| Placebo Group | Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Scratchy Throat | 4.3 days | Standard Deviation 3.8 |
Comparison: 0.05 global significance level (type I error rate)p-value: 0.704Wilcoxon (Mann-Whitney)
Secondary
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sneezing
For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days.
Time frame: Through study completion, up to Day 15
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healsea Rescue* Group | Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sneezing | 3.3 days | Standard Deviation 3.4 |
| Placebo Group | Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sneezing | 4.3 days | Standard Deviation 3.6 |
p-value: 0.0424Wilcoxon (Mann-Whitney)
Secondary
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sore Throat
For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days.
Time frame: Through study completion, up to Day 15
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healsea Rescue* Group | Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sore Throat | 3.9 days | Standard Deviation 3.7 |
| Placebo Group | Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sore Throat | 3.9 days | Standard Deviation 3.7 |
Comparison: 0.05 global significance level (type I error rate)p-value: 0.43Wilcoxon (Mann-Whitney)
Secondary
Subject Satisfaction Regarding Ease of Use of the Nasal Spray
At end of study visit (V2) subject satisfaction regarding ease of use will be recorded using a 4-points categorical scale (How would you characterize the use of Healsea® Rescue\* nasal spray? 0: not easy ; 1: pretty easy ; 2: easy ; 3: very easy).
Time frame: Between Day 13 and Day 15
Population: Full Analysis Set
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Healsea Rescue* Group | Subject Satisfaction Regarding Ease of Use of the Nasal Spray | use not easy | 0 Participants |
| Healsea Rescue* Group | Subject Satisfaction Regarding Ease of Use of the Nasal Spray | use pretty easy | 4 Participants |
| Healsea Rescue* Group | Subject Satisfaction Regarding Ease of Use of the Nasal Spray | use easy | 8 Participants |
| Healsea Rescue* Group | Subject Satisfaction Regarding Ease of Use of the Nasal Spray | use very easy | 88 Participants |
| Placebo Group | Subject Satisfaction Regarding Ease of Use of the Nasal Spray | use very easy | 87 Participants |
| Placebo Group | Subject Satisfaction Regarding Ease of Use of the Nasal Spray | use not easy | 1 Participants |
| Placebo Group | Subject Satisfaction Regarding Ease of Use of the Nasal Spray | use easy | 9 Participants |
| Placebo Group | Subject Satisfaction Regarding Ease of Use of the Nasal Spray | use pretty easy | 3 Participants |
Comparison: 0.05 global significance level (type I error rate)p-value: 1Fisher Exact